Since the beginning of vaccination against Covid-19 in Colombia -in February of this year- the number of people who have reported adverse effects after receiving the biological is minimal.
In fact, according to the second Pharmacovigilance report carried out by the Ministry of Health, Invima and the National Institute of Health (INS), less than 0.07% of immunized citizens have registered an adverse event, that is, in 13,390,951 Doses administered, 8,260 cases were reported (7,641 non-serious cases and 618 serious).
These results of the study -which took place between February 17 and June 15, 2021- “are favorable, with clear and conclusive findings that confirm that all the vaccines that are part of Colombia’s portfolio, in addition to being effective, are safe” , said Julián Fernández, director of Epidemiology and Demography of the Ministry of Health.
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In addition, he added: “In this analysis we found that the occurrence of adverse events after vaccination is less than 0.07%. The reporting rate shows that this is equivalent to 62 people for every 100,000 doses applied, ”he explained.
Meanwhile, in the Valley there have been 845 adverse effects, of these 797 have been mild, five adverse events that have been classified as serious, but not because the person has been in danger but because of an infection at the application site.
In Cali, of the more than a million doses applied against the covid (1,123,294 accumulated), only 28 mild cases have been reported, according to the municipal health secretary, Miyerlandi Torres, who stated: “really the symptoms are mild and surely due to that people do not report ”. In turn, he confirmed that there have been two serious cases, but “they were ruled out by the analysis table.”
In this sense, the epidemiologist Fernando de La Hoz, asserted that “this report reaffirms that vaccines are safe, what it shows is that apparently so far there have been no significant adverse reactions.”
The former director of the National Institute of Health, also specified that a person can have adverse events, that is, there is always a possibility, “because in any case he is doing a procedure that is to inoculate a person with a foreign substance to his body, then there is an immune response that, in some cases, could be too strong either in a localized way – in the arm – or it could be at a general level, but there are very low probabilities that it will occur.
Fortunately what the report shows is that it is very rare, ”he noted.
Likewise, de La Hoz explained that although the most recurrent are mild cases such as headache, the site of the application, muscular, dizziness, malaise and fever, serious cases can occur that “is one in which there is a generalized reaction, the person’s normal life may be affected, for example there may be an episode of fever with general malaise for several days; some kind of clinical picture that makes life difficult for a longer time; or they may have developed, for example, pneumonia, which is not attributable to the vaccine, but as it occurs after vaccination, it is studied ”.
He also added that “it can be a severe allergic reaction that requires hospitalization, such situations can be classified as serious reactions, they are rare things that suddenly are not due to the vaccine-against covid-, but since the vaccine was the last antecedent of which the person remembers, is studied as if it were related to the vaccine ”, clarified the specialist.
Meanwhile, the report also reveals that 79% of adverse effect reports were in women (6,381 cases) and 20% were men (1,785). Likewise, according to age, people between 30 and 39 years old registered the highest number of adverse reports -with 1,640 people-, and those between 20 and 29 years old registered 1,467 adverse cases.
Similarly, the Minsalud analysis shows that the vaccine developed by the pharmaceutical company Pfizer was the one with the highest reported adverse events with 6,332 cases, followed by Sinovac with 1,430 and AstraZeneca, with 493.
In this regard, the specialists clarify that these data cannot cast doubt on the safety or efficacy of the vaccine, since they are surveillance data and not research data.
“It cannot be established that there may be a greater effect of a vaccine compared to the others, because they are voluntary reports of people who had symptoms and decided to report it, but there may be others who did not report it,” stressed the epidemiologist from La Hoz.
The surveillance process
Leonardo Arregocés, Director of Medicines of the Ministry, explained that if a person feels bad after being vaccinated, they should consult the health services in a medical center where the situation in question will be addressed.
The official commented that “the IPS must attend to the patient’s situation, but they must also classify the event as mild or serious. When it comes to a serious event, they must notify it immediately ”. Serious cases reach the departmental Health Secretariat, where there must be a group of experts who evaluate the case, collect all the information, and establish whether or not such health situation is attributable to the vaccine.
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